Job Description

Global Study Associate Mississauga, CA; Warsaw, PL; Gothenburg, SE or Barcelona, ES Competitive salary and benefits Make a more meaningful impact to patients\xe2\x80\x99 lives around the globe Here you\xe2\x80\x99ll have the opportunity to make a meaningful difference to patients\xe2\x80\x99 lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines \xe2\x80\x93 for the world\xe2\x80\x99s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem. With deep roots and a proud heritage, AstraZeneca is a well-known brand and respected company, with a strong reputation in both the scientific community and academia. The Global Study Associate (GSA) supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviours. Typical accountabilities

• Support the GSD, GSAD and/or GSM by completing delegated study work as required. May work across many different studies and delivery models concurrently.
• Set-up, maintain and close the Trial Master File (TMF) as delegated by the GSD/GSAD. Ensure compliance to ICH-GCP and AZ SOPs.
• Interact/collaborate with internal and external stakeholders in collection of regulatory and other essential documents/information.
• Oversee the collection, review and track relevant study documents in the TMF.
• Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
• Contribute to and distribute meeting material and other varied forms of communication.
• Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Collate the administrative appendices for the Clinical Study Report.
• Set-up, populate and accurately maintain information in AZ tracking and communication tools (e.g. CTMS, SharePoint, MS Teams etc.) and support team members in the usage of these tools.

Essential criteria

• Administrative knowledge and basic knowledge in drug development and ICH-GCP
• Proven organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
• Ability to prioritize appropriately and to be adaptable
• Computer proficiency in day-to-day tasks
• Excellent verbal and written communication in English
• Demonstrate ability to work independently, as well as in a team environment

Desirable criteria

• Bachelor\xe2\x80\x99s degree (or higher)
• Education in medical or biological sciences or discipline associated with clinical research
• Study administration experience
• Experience within the pharmaceutical industry
• Experience in supporting clinical trials and study development

Why AstraZeneca At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. So, what\xe2\x80\x99s next? This role is open until the 29th January 2023. Where can I find out more? Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en